BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 9751930 · Received February 25, 2020

    Report

    Report Number
    2649622-2007-01061
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    March 1, 2007
    Report Date
    February 27, 2020
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB, (B)(6) 2004, 5076 IMPLANTABLE PACING LEAD, (B)(6) 2004, 5071 X2 IMPLANTABLE PACING LEAD, (B)(6) 2005. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB - (B)(6) 2004 5076 IMPLANTABLE PACING LEAD - (B)(6) 2004 5071 X2 IMPLANTABLE PACING LEAD - (B)(6) 2005. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED. THIS REPORT IS BEING SUBMITTED AS A RESULT OF A MISSING INITIAL REPORT AND SUPPLEMENTAL REPORT 002 IN EMDR FOR REPORT 2649622-2007-0106. AS A RESULT, THE INITIAL REPORT AND SUPPLEMENTAL REPORT 002 ARE BEING RESUBMITTED BY THE MANUFACTURER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS A RESULT OF A MISSING INITIAL REPORT AND SUPPLEMENTAL REPORT 002 IN EMDR FOR REPORT 2649622-2007-0106. AS A RESULT, THE INITIAL REPORT AND SUPPLEMENTAL REPORT 002 WERE RESUBMITTED BY THE MANUFACTURER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO NOISE. THERE WAS INCREASED IMPEDANCE OF 2500 OHMS, INCREASED THRESHOLDS, AND A LEAD FRACTURE. HIGH VOLTAGE THERAPIES WERE INACTIVATED. THE PHYSICIAN PLANS TO REPLACE THE LEAD, HOWEVER THE PATIENT REQUESTS TO WAIT UNTIL THIS FALL TO HAVE THE PROCEDURE DONE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO NOISE. THERE WAS INCREASED IMPEDANCE OF 2500 OHMS, INCREASED THRESHOLDS, AND A LEAD FRACTURE. HIGH VOLTAGE THERAPIES WERE INACTIVATED. THE PHYSICIAN PLANS TO REPLACE THE LEAD, HOWEVER THE PATIENT REQUESTS TO WAIT UNTIL THIS FALL TO HAVE THE PROCEDURE DONE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE RIGHT VENTRICULAR LEAD HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212142 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694965

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 5071 X2 IMPLANTABLE PACING LEAD